Immunocore scores several firsts, as FDA green lights its melanoma drug

America traded shares of Immunocore Holdings (Nasdaq: IMCR) were up 3.2% at $22.62 mid-morning, having hit $24.06 in earlier activity, after the UK biotech announced approval from the US Food and Drug Administration of Kimmtrak (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

Kimmtrak’s approval establishes many firsts as the first TCR therapeutic to receive regulatory approval from the FDA, the first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor, and the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA.

The approval was granted four weeks ahead of the FDA assigned PDUFA date of February 23, 2022. The company is ready to commercialize Kimmtrak and expects to make the product commercially available in the USA within weeks.